Stapleton 1986.
Study characteristics | ||
Methods |
Study objective: not provided Study design: randomised controlled trial Study grouping: parallel group Duration of follow‐up: not described Number of arms: 3 Single centre or multi‐site: single centre Study start date and end date: not described Setting: acute care setting |
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Participants |
Baseline characteristics Inclusion criteria: female elderly patients with fractured neck of femur, without existing pressure ulcers, Norton score 14 or less Exclusion criteria: patients did not meet the criteria, or admitted with existing pressure sores Sex (M:F): all female patients (0:32 in large cell Ripple; 0:34 in polyether foam pad; 0:34 in Spenco pad) Age (years): mean 81 across groups Baseline skin status: mean Norton score 12.0 in large cell Ripple; 12.8 in polyether foam pad; 12.9 in Spenco pad; no existing pressure ulcers Group difference: no difference Total number of participants: n = 100 Unit of analysis: individuals Unit of randomisation (per patient): individuals |
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Interventions |
Intervention characteristics Large Cell Ripple (Talley)
Polyether foam pad
Spenco pad
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Outcomes |
Proportion of participants developing a new pressure ulcer
Time to pressure ulcer development
Support‐surface‐associated patient comfort
All reported adverse events using allocated support surfaces
Health‐related quality of life (HRQOL)
Cost‐effectiveness
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “patients for the first two groups were selected by lottery, and thereafter patients were allocated to each group systematically, in rotation” Comment: unclear risk of bias because it is unclear if a proper randomisation method was applied. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no information provided. |
Selective reporting (reporting bias) | Unclear risk | Comment: no information provided. |
Other bias | Unclear risk | Comment: no information provided. |